肿瘤细胞治疗研究
英文原题：Tisagenlecleucel for post-transplant relapse in young acute lymphoblastic leukemia patients: European real-world determinants of outcome.
Tisagenlecleucel for post-transplant relapse in young acute lymphoblastic leukemia patients: European real-world determinants of outcome.
中位随访时间为30.0个月，2年无事件生存（EFS）率为43.6%，总生存（OS）率为67.2%，CAR-T治疗失败发生率为57.1%。
这项多中心真实世界研究确定了tisagenlecleucel（tisa-cel）治疗来自31个欧洲中心的220例B-ALL儿童/年轻成人HSCT后复发时结局的关键决定因素。中位随访时间为30.0个月，2年无事件生存（EFS）率为43.6%，总生存（OS）率为67.2%，CAR-T失败发生率为57.1%。与替代供者相比，接受匹配同胞供者（MSD）移植后复发时采用CAR-T治疗与较低的2年OS相关（MSD 59.1%，错配供者MMD 80.2%，匹配家族/无关供者MFD/MUD 68.3%，p = 0.046）。MSD的2年CAR-T失败发生率最高（MSD 73.8%，MFD/MUD 49.7%，MMD 52.2%，p = 0.006）。早期复发（HSCT后<6个月）患者的2年EFS（23.7%）和OS（47.2%）低于HSCT后6个月晚期复发患者（EFS 49.8%，p = 0.001；OS 73.9%，p < 0.001）。早期复发与更高的CAR-T失败发生率及tisa-cel后复发发生率相关，尤其是CD19+复发。结局与淋巴细胞清除时的疾病负荷相关：MRD-者的2年OS为81.7%，MRD+者为69.2%，未缓解患者为55.2%（p = 0.003），其中未缓解患者的CAR-T失败发生率最高。既往MSD移植、HSCT后早期复发以及淋巴细胞清除时的疾病负荷可识别HSCT后CAR-T失败风险增加的患者。
This multicenter real-world study identifies critical determinants of outcome for tisagenlecleucel (tisa-cel) in treating post-HSCT relapse in 220 children/young adults with B-ALL from 31 European centers. Median follow-up was 30.0 months, with a 43.6% 2-year event-free survival (EFS), 67.2% overall-survival (OS), and 57.1% incidence of CAR-T failure. CAR-T for relapse after transplant from a matched sibling donor (MSD) compared to alternative donors was associated with lower 2-year-OS (MSD 59.1%, mismatched donor MMD 80.2%, matched family/unrelated donor MFD/MUD 68.3%, p = 0.046). Two-year incidence of CAR-T failure was highest for MSD (MSD 73.8%, MFD/MUD 49.7%, MMD 52.2%, p = 0.006). Patients who had relapsed early (< 6 months post HSCT) showed inferior 2-year-EFS (23.7%) and OS (47.2%) compared to patients with late relapse, 6 months after HSCT (EFS 49.8%, p = 0.001; OS 73.9%, p < 0.001). Early relapse was associated with a higher incidence of CAR-T failure and relapse after tisa-cel, particularly CD19+ relapses. Outcomes correlated with disease burden at lymphodepletion: 2-year-OS was 81.7% for MRD-, 69.2% for MRD+, and 55.2% for patients in non-remission (p = 0.003), with incidence of CAR-T failure highest in non-remission. Prior transplant from an MSD, early post-HSCT relapse, and disease burden at lymphodepletion identify patients at increased risk of CAR-T failure after HSCT.
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